52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Overview[ - collapse ][ - ]
Purpose | Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin. |
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Condition | Type 2 Diabetes |
Intervention | Drug: Metformin Drug: Sulphonylurea Drug: Saxagliptin |
Phase | Phase 3 |
Sponsor | AstraZeneca |
Responsible Party | AstraZeneca |
ClinicalTrials.gov Identifier | NCT00575588 |
First Received | December 14, 2007 |
Last Updated | March 20, 2012 |
Last verified | March 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | December 14, 2007 |
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Last Updated Date | March 20, 2012 |
Start Date | December 2007 |
Estimated Primary Completion Date | August 2010 |
Current Primary Outcome Measures | Hemoglobin A1c (HbA1c) Change From Baseline to Week 52 [Time Frame: Baseline to 52 Weeks] [Designated as safety issue: No]Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period |
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Official Title | A 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone. |
Brief Summary | Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 2 Diabetes |
Intervention | Drug: Metformin open-label metformin Drug: Sulphonylurea Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) Drug: Saxagliptin Saxagliptin 5 mg tablets Other Names: Onglyza |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 891 |
Estimated Completion Date | August 2010 |
Estimated Primary Completion Date | August 2009 |
Eligibility Criteria | Inclusion Criteria: - Diagnosed with type 2 diabetes, - Treatment with metformin alone on stable doses of 1500 mg or higher per day for at least 8 weeks prior to Visit 1, - HbA1c >6.5% and ≤10.0% Exclusion Criteria: - Type 1 diabetes, - history of diabetic ketoacidosis or hyperosmolar non-ketonic coma, - Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Finland, Germany, Hungary, India, Korea, Republic of, Netherlands, Norway, Russian Federation, Slovakia, United Kingdom, Vietnam |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00575588 |
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Other Study ID Numbers | D1680C00001 |
Has Data Monitoring Committee | Yes |
Information Provided By | AstraZeneca |
Study Sponsor | AstraZeneca |
Collaborators | Bristol-Myers Squibb |
Investigators | Principal Investigator: Burkhard Goke University of Munich, GermanyStudy Director: Peter Ohman, MD AstraZenecaStudy Chair: Deborah Price, MSc AstraZeneca |
Verification Date | March 2012 |
Locations[ + expand ][ + ]
Research Site | Hanko, Finland |
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Research Site | Helsinki, Finland |
Research Site | Kuopio, Finland |
Research Site | Kuusankoski, Finland |
Research Site | Mikkeli, Finland |
Research Site | Oulu, Finland |
Research Site | Tampere, Finland |
Research Site | Aschaffenburg, Germany |
Research Site | Berlin, Germany |
Research Site | Dortmund, Germany |
Research Site | Frankfurt, Germany |
Research Site | Hamburg, Germany |
Research Site | Hannover, Germany |
Research Site | Mainz, Germany |
Research Site | Mannheim, Germany |
Research Site | Mulheim, Germany |
Research Site | Pirna, Germany |
Research Site | Ratzeburg, Germany |
Research Site | Reinfeld, Germany |
Research Site | Rhaunen, Germany |
Research Site | Schmiedeberg, Germany |
Research Site | Tubingen, Germany |
Research Site | Wahlstedt, Germany |
Research Site | Weinheim, Germany |
Research Site | Balatonfured, Hungary |
Research Site | Bekescsaba, Hungary |
Research Site | Budapest, Hungary |
Research Site | Debrecen, Hungary |
Research Site | Gyula, Hungary |
Research Site | Kalocsa, Hungary |
Research Site | Kaposvar, Hungary |
Research Site | Kecskemet, Hungary |
Research Site | Miskolc, Hungary |
Research Site | Mosonmagyarovar, Hungary |
Research Site | Nyiregyhaza, Hungary |
Research Site | Szekesfehervar, Hungary |
Research Site | Bangalore, Karnataka, India |
Research Site | Indore, Madhya Pradesh, India |
Research Site | Mumbai, Mashatra, India |
Research Site | Jaipur, Rajasthan, India |
Research Site | Guri, Gyeonggi-do, Korea, Republic of |
Research Site | Seongnam, Gyeonggi-do, Korea, Republic of |
Research Site | Wonju, Kangwon-do, Korea, Republic of |
Research Site | Incheon, Korea, Republic of |
Research Site | Seoul, Korea, Republic of |
Research Site | Uijeongbu-si, Korea, Republic of |
Research Site | Beek En Donk, Netherlands |
Research Site | Den Bosch, Netherlands |
Research Site | Den Haag, Netherlands |
Research Site | Deurne, Netherlands |
Research Site | Dordrecht, Netherlands |
Research Site | Losser, Netherlands |
Research Site | Nijverdal, Netherlands |
Research Site | Rijswijk, Netherlands |
Research Site | Roelofarendsveen, Netherlands |
Research Site | Rotterdam, Netherlands |
Research Site | Volendam, Netherlands |
Research Site | Bergen, Norway |
Research Site | Elverum, Norway |
Research Site | Flatasen, Norway |
Research Site | Hamar, Norway |
Research Site | Honefoss, Norway |
Research Site | Inderoy, Norway |
Research Site | Oslo, Norway |
Research Site | Radal, Norway |
Research Site | Skedsmokorset, Norway |
Research Site | Sogndal, Norway |
Research Site | Spikkestad, Norway |
Research Site | Trollasen, Norway |
Research Site | Kazan, Russian Federation |
Research Site | Moscow, Russian Federation |
Research Site | Nizhnii Novgorod, Russian Federation |
Research Site | St. Petersburg, Russian Federation |
Research Site | Yaroslavl, Russian Federation |
Research Site | Dolny Kubin, Slovakia |
Research Site | Kosice - Tahanovce, Slovakia |
Research Site | Moldava Nad Bodvou, Slovakia |
Research Site | Ruzomberok, Slovakia |
Research Site | Trnava, Slovakia |
Research Site | Zilina, Slovakia |
Research Site | Annan, Dumfries and Galloway, United Kingdom |
Research Site | Whitstable, Kent, United Kingdom |
Research Site | Hamilton, Lanarkshire, United Kingdom |
Research Site | Salford, Manchester, United Kingdom |
Research Site | Crawley, West Sussex, United Kingdom |
Research Site | Bradford-on-avon, Wiltshire, United Kingdom |
Research Site | Blackpool, United Kingdom |
Research Site | Coatbridge, United Kingdom |
Research Site | Coventry, United Kingdom |
Research Site | Glasgow, United Kingdom |
Research Site | Motherwell, United Kingdom |
Research Site | Newcastle, United Kingdom |
Research Site | Sheffield, United Kingdom |
Research Site | Ho Chi Minh, Vietnam |
Research Site | Ho Chi Minh City, Vietnam |